Addressing clinical research on a medical device has never been an easy task. You learn that as soon as you enter this world. Until relatively recently, the situation was that research on medical devices was like trying to clean up a somewhat messy drawer. And it is that in the end, research in medical devices has always moved between the most lax legislation of a cosmetic, and what has always been understood as a true clinical trial of drugs. Medical devices have fought the battle of what to do, how to do it and, above all, who to turn to when you no longer know how to set up a clinical study.
In clinical investigation with medical devices, there are different situations that must be clearly differentiated in order to know the requirements applicable to each one of them, from a product that is marketed to another that is not, to products that are in the barrier between being cosmetic, medical device or drug, and even the fashionable food supplements, which often also require the authorization of a clinical investigation by an Ethics Committee (hereinafter CEIm).
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Iván Parra
Comercial Director
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